LVivo Software Application

Evidence summary

The exact FDA clinical validation included 170 examinations; among 139 automatically processed examinations, modified WMSI sensitivity was 82%, specificity 79%, accuracy 82%, and Pearson correlation with the reference was 0.89.

FDA source Exact FDA submission Checked 2026-09-06

• Source

Postmarket safety review

Not established in reviewed sources

Reviewed sources checked Exact FDA submission Checked 2026-09-04

No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.

• Verify deployment and data flow: Attach an exact-product deployment and data-flow source.
• Verify security and privacy controls: No current exact-release security attestation was established.
• Verify training: Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
• Verify pricing and total cost: No numeric price was published in the reviewed sources.
• Verify reimbursement and coding relevance: Determine whether any product-specific CPT/HCPCS pathway exists and separate it from billing for the underlying imaging service.
• Verify local validation and lifecycle monitoring: Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
• Verify recalls and postmarket safety signals: No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.

The stored candidate metadata contained empty PubMed and clinical-trial ID arrays; metadata was screened, not full-text or registry-reviewed. The stored recall candidate record was empty and no event was promoted. The current discovery snapshot contains 0 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.

Source classes: fda ai list, fda decision summary, acr ai central product, vendor product page, vendor manual, vendor press release, peer reviewed publication, clinical trial registry, recall database, pubmed, clinical trials, openfda device recall

• K243862 FDA decision source U.S. Food and Drug Administration · 2026-08-31
• Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
• LVivo Software Application model card (K243862) American College of Radiology · 2026-09-01
• PubMed biomedical literature index U.S. National Library of Medicine · 2026-09-01
• ClinicalTrials.gov study registry U.S. National Library of Medicine · 2026-09-01
• openFDA Device Recall API U.S. Food and Drug Administration · 2026-09-02
• FDA 510(k) decision record and summary reviewed for LVivo Software Application, K243862 U.S. Food and Drug Administration · 2026-09-06
• LVivo EF App support article GE HealthCare · 2026-09-07
• Konica Minolta and DiA expand AI-based echocardiography analysis and reporting on Exa Cardio PACS Konica Minolta Healthcare Americas and DiA Imaging Analysis · 2026-09-07